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MA069

Product Details
WHO Product ID
MA069
Status
Prequalified
INN, dosage form and strength
Artemether/Lumefantrine Tablet, Dispersible 20mg/120mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Malaria
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Dispersible
Reference authority
Swiss Agency for Therapeutic Products
Applicant organization
Novartis Pharma AG
Lichtstrasse 35
Basel,
4002
Switzerland
Packaging details and storage conditions
Packaging Type
Blister, Alu/PVC/PE/PVdC
Configuration
6x1, 6x2, 6x30, 12x30
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture, protect from light
API Manufacturing Site(s)
By Organization
By Active Ingredient
KPC Pharmaceuticals Inc
Small Volume Injection Plant, Qigongli (W)
Kunming,
Yunnan
650 100
China
Artemether
Shanghai Desano Chemical Pharmaceutical Co. Ltd.
417 Binhai Road, Laogang Town, Pudong New Area
Shanghai
201302
China
Lumefantrine
Zhejiang Lyee Biotechnology Co Ltd
No. 69 Luoxin Road, The North Division, Economic Development Zone
Shengzhou,
Zhejiang
312 400
China
Lumefantrine
Zhejiang Medicine Co Ltd
98 East Dadao Road
Xinchang,
Zhejiang
312 500
China
Artemether, Lumefantrine
FPP Manufacturing Site(s)
Novartis Saglik
Gida ve Tarim Urunleri San. Ve Tic. A.S., Yenişehir Mahallesi Ihlara Vadisi Sokak No. 2, Pendik
Istanbul,
TR 34912
Türkiye
FPP Packaging Only
Anderson Brecon Inc
4545 Assembly Drive
Rockford,
61109
United States of America
Novartis Pharma AG
No 31 Yongan Road, Nanguan Chengguan Township, Changping District
Beijing,
Beijing
102 200
China
Packaging Coordinators Inc
3001 Red Lion Drive
Philadelphia,
PA 19114
United States of America
Sharp Corporation
23 Carland Road
Conshohocken,
19428
United States of America
WHO Public Assessment Reports


Additional product information "Basic Patient Leaflet" - according to the supplier this information is included in the pack when the product is distributed outside of the Swiss market. It should be noted that this information has neither been prequalified nor approved by Swissmedic.

Part 1 - Abstract
Part 2 - All accepted presentations (including photo)
Part 3 - WHO-PQ recommended patient information leaflet*
Part 4 - WHO-PQ recommended summary of product characteristics*
Part 5 - Label
Part 6 - Discussion (status at the time of prequalification)
Part 7 - Steps before Prequalification
Part 8 - Steps following Prequalification (from 01 March 2014, only changes to the published information are included)

* This summary of product characteristics/patient information leaflet focus on uses of the medicine covered by WHO Prequalification Team - Medicines. The recommendations for use are based on WHO guidelines and on information from stringent regulatory authorities (term to be revised). The medicine may be authorised for additional or different uses by national medicines regulatory authorities. 

 

Part 1 , Part 2 , Part 3 , Part 4 , Part 5 , Part 7

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